Active not recruitingNAINTERVENTIONAL

Performance and Adherence in Children Using Spacers

Asthma makes breathing hard for many children. Inhalers help, but they need to be used correctly to work best. This study is for children aged 6 to 18 who have asthma and use inhalers with a spacer. We know that many children don't use their inhalers perfectly, which can lead to more asthma symptoms. This study will use a 'Smart Spacer' to see exactly when and how children use their inhalers. Researchers want to find out if giving children and their families special advice on how to use their inhalers, compared to standard advice, can help control asthma better. The aim is to help children have fewer asthma problems and improve their daily lives.

At a glance

Status

Active not recruiting

Phase

Sponsor

University Hospitals of North Midlands NHS Trust

Enrolment target

Start

01 Sep 2022

Estimated completion

31 Dec 2026

Asthma Asthma in Children

What is this study about?

Asthma is a common condition that can make it difficult to breathe because the airways in the lungs become swollen. It affects about 1 in 11 children in the UK. Inhalers are a really important way to treat asthma by reducing this swelling. When children use their inhalers correctly, it can help keep their asthma under control, meaning they can play, learn, and live their lives with fewer worries about asthma attacks.

However, it's quite common for children not to use their inhalers perfectly. Sometimes they don't use them enough, which means their asthma isn't as well-controlled as it could be. Other times, they might use them too much, which can lead to side effects. Because of this, even though inhalers are effective, many children still struggle with their asthma symptoms. Doctors and nurses find it challenging to know exactly how well children are using their inhalers between their clinic visits.

This study wants to learn more about how children and young people (aged 6 to 18) truly use their inhalers. We'll be using a special device called a 'Smart Spacer' which can record when and how effectively an inhaler is used. Half the children in the study will get personalised advice and training on how to use their inhaler, while the other half will get the usual advice. By doing this, we hope to understand if personalised training helps children control their asthma better. The overall goal is to find better ways to help children manage their asthma so they can live healthier, more active lives.

Key takeaways

This study is for children and young people aged 6-18 with asthma.
It uses a 'Smart Spacer' to understand how inhalers are used.
The study compares standard advice to personalised advice on inhaler use.
The goal is to improve asthma control and reduce asthma symptoms.
Participation lasts about 12 weeks and involves clinic visits and breathing tests.

Who may be eligible?

You might be able to take part in this study if you are a child or young person between 6 and 18 years old who has been diagnosed with asthma and sees a specialist doctor or nurse for your asthma care. You also need to be using a preventer inhaler twice a day with a spacer device (sometimes called a valved holding chamber).

It's important that you (or your parent/guardian if you're under 16) are happy to officially agree to be part of the study and follow the study's instructions. You should also be able to do some simple breathing tests.

However, you won't be able to join if you have another serious lung condition like cystic fibrosis, or if you're already taking part in another study that involves trying new medicines or medical devices. Also, if you don't speak English and we can't arrange for a good translator, you might not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 6 and 18 years old?
Do you have an asthma diagnosis and see a specialist for it?
Do you use a preventer inhaler twice a day with a spacer?
Are you (or your parent/guardian) willing to give permission to join and follow study instructions?
Do you *not* have another serious lung condition like cystic fibrosis?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of it for about 12 weeks. During this time, you'll be given a special 'Smart Spacer' which will track how you use your inhaler. You won't have to change your asthma medicine, but you'll continue to use your regular preventer inhaler with this new spacer.

You'll be invited to a few visits at the clinic. At these visits, doctors and nurses will assess your asthma, and you'll do some simple breathing tests. You'll also receive advice on how to use your inhaler. Depending on which group you're randomly placed in, this advice will either be standard advice, or more personalised and tailored to you.

Throughout the study, you'll continue with your usual asthma care. The aim is to understand how your asthma control changes over these 12 weeks with the Smart Spacer and the education you receive. After the 12 weeks, your participation in the study will be complete.

Potential risks and benefits

By taking part, you might benefit from more focused attention on your inhaler technique, which could lead to better asthma control and fewer symptoms. However, there's no guarantee that your asthma will improve. There are very few risks involved; you'll be using your regular asthma medicine, and the Smart Spacer is a monitoring device. The breathing tests are routine and safe. You are free to withdraw from the study at any time, for any reason, without it affecting your usual asthma care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Robert James Bowler
Verified postcode
Stoke-on-Trent, United Kingdom

Common questions

What is a 'Smart Spacer'?

It's a special device you use with your inhaler, like a regular spacer, but it also records when and how you use your inhaler.

Will I have to change my asthma medicine?

No, you will keep taking your usual asthma preventer medicine. The study is about how you use it with the spacer.

How long will the study last for me?

If you join, you will be part of the study for about 12 weeks.

Will my information be kept private?

Yes, all your personal information will be kept confidential and secure.

Can I leave the study at any time?

Yes, you are free to leave the study whenever you want, and your asthma care will not be affected.